The following data is part of a premarket notification filed by Cordis, A Cardinal Health Company with the FDA for 4f Infiniti Angiographic Catheter, 4f & 5f Nylex Angiography Catheters, 4f & 5f Tempo Angiography Catheters.
| Device ID | K181836 |
| 510k Number | K181836 |
| Device Name: | 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cordis, A Cardinal Health Company 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Contact | Vidya Venkataeaghavan |
| Correspondent | Vidya Venkataeaghavan Cordis, A Cardinal Health Company 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-10 |
| Decision Date | 2018-08-08 |
| Summary: | summary |